PlainRecalls
FDA Devices Moderate Class II Ongoing

Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.

Reported: August 31, 2022 Initiated: July 26, 2022 #Z-1574-2022

Product Description

Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.

Reason for Recall

Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is implanted with more than one neurostimulator.

Details

Recalling Firm
Medtronic Neuromodulation
Units Affected
4386 downloaded software applications
Distribution
Worldwide distribution - US distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico. The countries of Austria, Belgium, Canada, Canary Islands, Cayman Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.. Recalled by Medtronic Neuromodulation. Units affected: 4386 downloaded software applications.
Why was this product recalled?
Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is implanted with more than one neurostimulator.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 31, 2022. Severity: Moderate. Recall number: Z-1574-2022.